A joint task force composed of members from the American Urological Association (AUA) and the American Society for Radiation Oncology (ASTRO) has presented formal guidelines for the use of adjuvant and salvage radiation after a radical prostatectomy. To construct the Guideline they relied on a systematic review of the literature using the Pubmed, Embase and Cochrane databases (search dates 1/1/90 to 12/15/12) to identify peer-reviewed publications relevant to the use of radiotherapy after prostatectomy.
They assigned a rating of the strength of the evidence that was used to draw a conclusion, with a strength rating of A (high quality evidence; high certainty), B (moderate quality evidence; moderate certainty) or C (low quality evidence; low certainty) and evidence-based statements of Standard, Recommendation or Option were developed. Additional information is provided as Clinical Principles and Expert Opinion when insufficient evidence existed.
Guideline Statement 1. Patients who are being considered for management of localized prostate cancer with radical prostatectomy should be informed of the potential for adverse pathologic findings that portend a higher risk of cancer recurrence and that these findings may suggest a potential benefit of additional therapy after surgery. (Clinical Principle)
Guideline Statement 2. Patients with adverse pathologic findings including seminal vesicle invasion, positive surgical margins, and extraprostatic extension should be informed that adjuvant radiotherapy, compared to radical prostatectomy only, reduces the risk of biochemical (PSA) recurrence, local recurrence, and clinical progression of cancer. They should also be informed that the impact of adjuvant radiotherapy on subsequent metastases and overall survival is less clear; one of two randomized controlled trials that addressed these outcomes indicated a benefit but the other trial did not demonstrate a benefit. However, the other trial was not powered to test the benefit regarding metastases and overall survival. (Clinical Principle)
Guideline Statement 3. Physicians should offer adjuvant radiotherapy to patients with adverse pathologic findings at prostatectomy including seminal vesicle invasion, positive surgical margins, or extraprostatic extension because of demonstrated reductions in biochemical recurrence, local recurrence, and clinical progression. (Standard; Evidence Strength: Grade A)
Guideline Statement 4. Patients should be informed that the development of a PSA recurrence after surgery is associated with a higher risk of development of metastatic prostate cancer or death from the disease. Congruent with this clinical principle, physicians should regularly monitor PSA after radical prostatectomy to enable early administration of salvage therapies if appropriate.(Clinical Principle)
Guideline Statement 5. Clinicians should define biochemical recurrence as a detectable or rising PSA value after surgery that is ? 0.2 ng/ml with a second confirmatory level ? 0.2 ng/ml. (Recommendation; Evidence Strength: Grade C)
Guideline Statement 6. A restaging evaluation in the patient with a PSA recurrence may be considered. (Option; Evidence Strength: Grade C)
Guideline Statement 7. Physicians should offer salvage radiotherapy to patients with PSA or local recurrence after radical prostatectomy in whom there is no evidence of distant metastatic disease. (Recommendation; Evidence Strength: Grade C)
Guideline Statement 8. Patients should be informed that the effectiveness of radiotherapy for PSA recurrence is greatest when given at lower levels of PSA. (Clinical Principle)
Guideline Statement 9. Patients should be informed of the possible short-term and long-term urinary, bowel, and sexual side effects of radiotherapy as well as of the potential benefits of controlling disease recurrence. (Clinical Principle)
The committee acknowledged that there were a number of significant limitations that they faced when constructing these guidelines. They acknowledged that a major limitation they faced was the lack of a large number of randomized controlled trials to guide decision-making in patients with and without evidence of recurrence and to indicate the appropriate use of androgen deprivation therapies in these patients. They also acknowledged that there is a change in characteristics of contemporary patients as a result of increased prostate cancer screening seen today.
The Guideline may be viewed at: AUA/ASTRO Guideline
What is the significance of these guidelines? Many of them involve giving information to patients and their families and joint decision-making between a doctor and patient. Many of the guidelines come solely with evidence rating of C, not a high recommendation. What will medical insurance payees do with this information? These are all significant and important concerns which only time will tell us how they get used.
I am happy that so many of the guidelines recommend that there be joint decision making between the doctor and the patient. I am also very pleased to see that the guidelines include complete disclosure of possible side effects of treatments, something that often does not happen in the real world.
Joel T Nowak, M.A., M.S.W.